While it's long been known that smoke can be dangerous when in the thick of it — triggering asthma attacks, cardiac arrests, hospitalizations and more — the Seeley Lake research confirmed what public health experts feared: Wildfire haze can have consequences long after it's gone.
This article was published on Friday, September 18, 2020 in Kaiser Health News.
SEELEY LAKE, Mont. — When researchers arrived in this town tucked in the Northern Rockies three years ago, they could still smell the smoke a day after it cleared from devastating wildfires. Their plan was to chart how long it took for people to recover from living for seven weeks surrounded by relentless smoke.
They still don’t know, because most residents haven’t recovered. In fact, they’ve gotten worse.
Forest fires had funneled hazardous air into Seeley Lake, a town of fewer than 2,000 people, for 49 days. The air quality was so bad that on some days the monitoring stations couldn’t measure the extent of the pollution. The intensity of the smoke and the length of time residents had been trapped in it were unprecedented, prompting county officials to issue their first evacuation orders due to smoke, not fire risk.
Many people stayed. That made Seeley Lake an ideal place to track the long-term health of people inundated by wildfire pollution.
So far, researchers have found that people’s lung capacity declined in the first two years after the smoke cleared. Chris Migliaccio, an immunologist with the University of Montana, and his team found the percentage of residents whose lung function sank below normal thresholds more than doubled in the first year after the fire and remained low a year after that.
“There’s something wrong there,” Migliaccio said.
While it’s long been known that smoke can be dangerous when in the thick of it — triggering asthma attacks, cardiac arrests, hospitalizations and more — the Seeley Lake research confirmed what public health experts feared: Wildfire haze can have consequences long after it’s gone.
That doesn’t bode well for the 78 million people in the western United States now confronting historic wildfires.
Toxic air from fires has blanketed California and the Pacific Northwest for weeks now, causing some of the world’s worst air quality. California fires have burned roughly 2.3 million acres so far this year, and the wildfire season isn’t over yet. Oregon estimates 500,000 people in the state have been under a notice to either prepare to evacuate or leave. Smoke from the West Coast blazes has drifted as far away as Europe.
Extreme wildfires are predicted to become a regular occurrence due to climate change. And, as more people increasingly settle in fire-prone places, the risks increase. That’s shifted wildfires from being a perennial reality for rural mountain towns to becoming an annual threat for areas across the West.
Dr. Perry Hystad, an associate professor in the College of Health and Human Sciences at Oregon State University, said the Seeley Lake research offers unique insights into wildfire smoke’s impact, which until recently had largely been unexplored. He said similar studies are likely to follow because of this fire season.
“This is the question that everybody is asking,” Hystad said. “‘I’ve been sitting in smoke for two weeks, how concerned should I be?’”
Migliaccio wants to know whether the lung damage he saw in Seeley Lake is reversible — or even treatable. (Think of an inhaler for asthma or other medication that prevents swollen airways.)
But those discoveries will have to wait. The team hasn’t been able to return to Seeley Lake this year because of the coronavirus pandemic.
Migliaccio said more research is needed on whether wildfire smoke damages organs besides the lungs, and whether routine exposure makes people more susceptible to diseases.
“Now you have the combination of flu season and COVID and the wildfires,” Migliaccio said. “How are all these things going to interact come late fall or winter?”
A Case Study
Seeley Lake has long known smoke. It sits in a narrow valley between vast stretches of thick forests.
On a recent September day, Boyd Gossard stood on his back porch and pointed toward the mountains that were ablaze in 2017.
Gossard, 80, expects to have some summer days veiled in haze. But that year, he said, he could hardly see his neighbor’s house a few hundred feet away.
“I’ve seen a lot of smoke in my career,” said Gossard, who worked in timber management and served as a wildland firefighter. “But having to just live in it like this was very different. It got to you after a while.”
When Missoula County health officials urged people to leave town and flee the hazardous smoke, many residents stayed close to home. Some said their jobs wouldn’t let them leave. Others didn’t have a place to go — or the money to get there.
Health officials warned those who stayed to avoid exercising and breathing too hard, to remain inside and to follow steps to make their homes as smoke-free as possible. The health department also worked to get air filters to those who needed them most.
But when flames got too close, some people had to sleep outside in campsites on the other side of town.
Understanding the Science of Smoke
One of the known dangers of smoke is particulate matter. Smaller than the width of a human hair, it can bypass a body’s defenses, lodging deep into lungs. Lu Hu, an atmospheric chemist with the University of Montana, said air quality reports are based on how much of that pollution is in the air.
“It’s like lead; there’s no safe level, but still we have a safety measure for what’s allowable,” Hu said. “Some things kill you fast and some things kill you slowly.”
While air quality measurements can gauge the overall amount of pollution, they can’t assess which specific toxins people are inhaling. Hu is collaborating with other scientists to better predict how smoke travels and what pollutants people actually breathe.
He said smoke’s chemistry changes based on how far it travels and what’s burning, among other factors.
Over the past few years, teams of researchers drove trucks along fire lines to collect smoke samples. Other scientists boarded cargo planes and flew into smoke plumes to take samples right from a fire’s source. Still others stationed at a mountain lookout captured smoke drifting in from nearby fires. And ground-level machines at a Missoula site logged data over two summers.
Bob Yokelson, a longtime smoke researcher with the University of Montana, said scientists are getting closer to understanding its contents. And, he said, “it’s not all bad news.”
Temperature and sunlight can change some pollutants over time. Some dangerous particles seem to disappear. But others, such as ozone, can increase as smoke ages.
Yokelson said scientists are still a long way from determining a safe level of exposure to the 100-odd pollutants in smoke.
“We can complete the circle by measuring not only what’s in smoke, but measuring what’s happening to the people who breathe it,” Yokelson said. “That’s where the future of health research on smoke is going to go.”
Coping With Nowhere to Flee
In the meantime, those studying wildland smoke hope what they’ve learned so far can better prepare people to live in the haze when evacuation isn’t an option.
Joan Wollan, 82, was one of the Seeley Lake study participants. She stayed put during the 2017 fire because her house at the time sat on a border of the evacuation zone.
The air made her eyes burn and her husband cough. She ordered air filters to create cleaner air inside her home, which helped.
On a recent day, the air in Wollan’s new neighborhood in Missoula turned that familiar gray-orange as traces of fires from elsewhere appeared. Local health officials warned that western Montana could get hit by some of the worst air quality the state had seen since those 2017 fires.
If it got bad enough, Wollan said, she’d get the filters out of storage or look for a way to get to cleaner air — “if there is someplace in Montana that isn’t smoky.”
Industry experts say Florida is likely to be the first state to win federal approval for a drug importation plan — something that could occur before the November election.
This article was published on Friday, September 18, 2020 in Kaiser Health News.
Over the objections of drugmakers, the Trump administration is expected within weeks to finalize its plan that would allow states to import some prescription medicines from Canada.
Six states — Colorado, Florida, Maine, New Hampshire, New Mexico and Vermont — have passed laws allowing them to seek federal approval to buy drugs from Canada to give their residents access to lower-cost medicines.
But industry observers say the drug importation proposal under review by the administration is squarely aimed at Florida — the most populous swing state in the November election. Trump’s support of the idea initially came at the urging of Florida Gov. Ron DeSantis, a close Republican ally.
The DeSantis administration is so confident Trump will move ahead with allowing drug importation that it put out a request June 30 for private companies to bid on a three-year, $30 million contract to run the program. It hopes to award the contract in December.
Industry experts say Florida is likely to be the first state to win federal approval for a drug importation plan — something that could occur before the November election.
“Approving Florida would feel like the politically astute thing to do,” said Mara Baer, a Colorado-based health consultant who has worked with Florida on its importation proposal.
Ben England, CEO of FDAImports, a consulting firm in Glen Burnie, Maryland, said the OMB typically has 60 days to review final rules, although he expects this one could be completed before Nov. 3 and predicted there’s a small chance it could get finalized and Florida’s request approved by then. “It’s an election year, so I do see the current administration trying to use this as a talking point to say ‘Look what we’ve accomplished,’” he said.
Florida also makes sense because of the large number of retirees, who face high costs for medicines despite Medicare drug coverage.
The DeSantis administration did not respond to requests for comment.
Trump boasted about his importation plan during an October speech in The Villages, a large retirement community about 60 miles northwest of Orlando. “We will soon allow the safe and legal importation of prescription drugs from other countries, including the country of Canada, where, believe it or not, they pay much less money for the exact same drug,” Trump said, with DeSantis in attendance. “Stand up, Ron. Boy, he wants this so badly.”
The Food and Drug Administration released a detailed proposal last December and sought comments. A final plan was delivered Sept. 10 to the Office of Management and Budget for review, signaling it could be unveiled within weeks.
The proposal would regulate how states set up their own programs for importing drugs from Canada.
Prices are cheaper because Canada limits how much drugmakers can charge for medicines. The United States lets free markets dictate drug prices.
The pharmaceutical industry signaled it will likely sue the Trump administration if it goes forward with its importation plans, saying the plan violates several federal laws and the U.S. Constitution.
But the most stinging rebuke of the Trump importation plan came from the Canadian government, which said the proposal would make it harder for Canadian citizens to get drugs, putting their health at risk.
“Canada will employ all necessary measures to safeguard access for Canadians to needed drugs,” the Canadian government wrote in a letter to the FDA about the draft proposal. “The Canadian drug market and manufacturing capacity are too small to meet the demand of both Canadian and American consumers for prescription drugs.”
Without buy-in from Canada, any plan to import medicines is unlikely to succeed, officials said.
Ena Backus, director of Health Care Reform in Vermont, who has worked on setting up an importation program there, said states will need help from Canada. “Our state importation program relies on a willing partner in Canada,” she said.
For decades, Americans have been buying drugs from Canada for personal use — either by driving over the border, ordering medication on the internet or using storefronts that connect them to foreign pharmacies. Though illegal, the FDA has generally permitted purchases for individual use.
The practice has been popular in Florida. More than a dozen storefronts across the state help consumers connect to pharmacies in Canada and other countries. Several cities, state and school districts in Florida help employees get drugs from Canada.
The administration’s proposal builds on a 2000 law that opened the door to allowing drug importation from Canada. But that provision could take effect only if the Health and Human Services secretary certified importation as safe, something that Democratic and Republican administrations have refused to do.
The drug industry for years has said allowing drugs to be imported from Canada would disrupt the nation’s supply chain and make it easier for unsafe or counterfeit medications to enter the market.
Trump, who made lowering prescription drug prices a signature promise in his 2016 campaign, has been eager to fulfill his pledge. In July 2019, at Trump’s direction, HHS Secretary Alex Azar said the federal government was “open for business” on drug importation, a year after calling drug importation a “gimmick.”
The administration envisions a system in which a Canadian-licensed wholesaler buys directly from a manufacturer for drugs approved for sale in Canada and exports the drugs to a U.S. wholesaler/importer under contract to a state.
Florida’s legislation — approved in 2019 — would set up two importation programs. The first would focus on getting drugs for state programs such as Medicaid, the Department of Corrections and county health departments. State officials said they expect the programs would save the state about $150 million annually.
The second program would be geared to the broader state population.
In response to the draft rule, the states seeking to start a drug importation program suggested changes to the administration’s proposal.
“Should the final rule not address these areas of concern, Colorado will struggle to find appropriate partners and realize significant savings for consumers,” Kim Bimestefer, executive director of the Colorado Department of Health Care Policy & Financing, told the FDA in March.
Among the state’s concerns is that it would be limited to using only one Canadian wholesaler, and without competition the state fears prices might not be as low as officials hoped. Bimestefer also noted that under the draft rule, the federal government would approve the importation program for only two years and states need a longer time frame to get buy-in from wholesalers and other partners.
Colorado officials estimate importing drugs from Canada could cut prices by 54% for cancer drugs and 75% for cardiac medicines. The state also noted the diabetes drug Jardiance costs $400 a month in the United States and sells for $85 in Canada.
Several states worry some of the most expensive drugs — including injectable and biologic medicines — were exempt from the federal rule. Those drug classes are not allowed to be imported under the 2000 law.
However, in an executive order in July, Trump said he would allow insulin to be imported if Azar determined it is required for emergency medical care. An HHS spokesman would not say whether Azar has done that.
Jane Horvath, a health policy consultant in College Park, Maryland, said the administration faces several challenges getting an importation program up and running, including possible opposition from the pharmaceutical industry and limits on classes of drugs that can be sold over the border.
“Despite the barriers, the programs are still quite worthwhile to pursue,” she said.
Maine’s top health official said the administration should work with the Canadian government to address Canada’s concerns. HHS officials refused to say whether such discussions have started.
Officials in Vermont, where the program would also include consumers covered by private insurance, remain hopeful.
“Given that we want to reduce the burden of health care costs on residents in our state, then it is important to pursue this option if there is a clear pathway forward,” Backus said.
From the moment she learned she was pregnant late last year, TaNefer Camara knew she didn't want to have her baby in a hospital bed.
Already a mother of three and a part-time lactation consultant at Highland Hospital in Oakland, Camara knew a bit about childbirth. She wanted to deliver at home, surrounded by her family, into the hands of an experienced female birth worker, as her female ancestors once did. And she wanted a Black midwife.
It took the COVID-19 pandemic to get her husband on board. "Up until then, he was like, 'You're crazy. We're going to the hospital,'" she said.
As the COVID-19 pandemic has laid bare healthcare inequities, more Black women are looking to home birth as a way not only to avoid the coronavirus but also to shun a health system that has contributed to African American women being three to four times more likely to die of childbirth-related causes than white women, regardless of income or education. Researchers argue that the roots of this disparity — one of the widest in women's healthcare — lie in long-standing social inequities, from lack of safe housing and healthy food to inferior care provided at the hospitals where Black women tend to give birth.
"It feels like we are needed," said midwife Kiki Jordan, who co-owns Birthland, a prenatal practice that opened early this year in a 400-square-foot storefront in Oakland's Temescal neighborhood targeting low-income women of color.
Since the COVID-19 pandemic hit in March, she said, the practice's clientele has more than tripled.
Images of hospitals inundated with coronavirus patients have sparked a flurry of new interest among women of all races in home births, which account for just over 1% of deliveries in the United States. Birth centers and midwives who attend home births say they've been swamped by new clients since the pandemic.
"Every midwife I'm talking to has seen their practice double or sometimes triple in the wake of COVID," said Jamarah Amani, a Florida midwife and co-founder of the National Black Midwives Alliance.
Many Americans think of giving birth at home as backward and scary, or as a quixotic practice of privileged white women, akin to cloth diaper services and home-cooked baby food.
But the growing interest in home births in recent years has fueled a growing Black midwifery movement that harks back to a venerable, if long-forgotten, tradition in the United States.
Jordan's practice is now 98% Black, "something I've never seen before," she said. She provides pre- and postnatal care regardless of where women plan to deliver, though the majority of her clientele choose home births.
African American infants are more than twice as likely to die as white infants, and the risks extend across social class. Tennis superstar Serena Williams' harrowing 2018 account of her own near-death postpartum experience with a blood clot in her lungs and a cascade of life-threatening complications was a sobering reminder that even wealth and fame are no protection from being dismissed or mistreated during one of the most vulnerable moments of a woman's life.
At least three Black women have diedin childbirth since March in New York City, which was hit hard early on by the coronavirus. One of the women, 26-year-old Amber Isaac, had reportedly tried to switch to a home or birth-center delivery after not getting an in-person appointment with her obstetrician as providers abruptly switched to telemedicine in the wake of the shutdown.
For Katrina Ayoola, 29, avoiding unnecessary medical interventions that researcherssay can leadto dangerous maternal complications was a key reason for switching to a home birth. As the coronavirus hit last spring, when Ayoola was around five months pregnant with her first baby, she was already frustrated with her obstetricians in Martinez, California. She didn't like their system of rotating providers, to whom she felt she constantly had to reexplain herself. The last straw was being told to go shopping for a home blood pressure monitor. They were sold out everywhere. "I ended up canceling what would have been an online appointment, and I haven't heard from them since," said Ayoola.
"I did not feel cared for," she said.
On Aug. 1, Ayoola delivered her son, Oluwatayo, at home in Fairfield with her husband, Daré, and her mother at her side following a 29-hour labor supervised by Jordan and her partner, Anjali Sardeshmukh.
"At the hospital, I'd probably have had a C-section," said Ayoola, who said her home birth was "an amazing, empowering experience," worth every penny of the out-of-pocket $4,500 the couple paid for it — a discount, based on their insurance and income, from Birthland's typical $6,500 fee.
Cost is a major barrier for poor people to access out-of-hospital births. Medicaid, the federal-state health insurance program that covers many low-income pregnant women, pays for home births in only a handful of states. Since 2015 these have included California, but reimbursement is low and bureaucratic requirements make it difficult for most midwives to accept Medi-Cal, California's Medicaid program. A quarter of U.S. states do not even offer midwife licenses, making the practice of home birth effectively illegal.
Jordan led a free-standing birth center in San Rafael that was the first in the state to accept Medi-Cal when it opened in 2016. She and a handful of other Black midwives around the country are leading the effort to make out-of-hospital births more accessible to low-income women, a group that could particularly benefit from community-based midwifery, according to a 2018 study.
Many of these birth workers are struggling to break even, but that's nothing new.
In past generations, Black midwives sometimes walked miles and stayed days with laboring women, massaging their feet, cooking and babysitting, and reading from the Bible in exchange for a few dollars or a chicken, according to historicalaccounts. Immigrants and African Americans dominated midwifery during much of this country's history, and in the South, enslaved women passed from mother to daughter childbirth techniques and remedies brought from West Africa starting in the 1600s.
In certain rural pockets, Black midwives continued to deliver babies for poor Black and white families alike, even into the last century, as modern obstetrics regulated traditional birth attendants virtually out of existence. Midwives delivered half of the nation's babies in 1900 and just over 10% by the 1930s, as physicians launched a campaign to promote hospital birth as safe and hygienic, while dismissing midwives as "relics of barbarism."
But in recent years, with hospital birth as the norm, the United States has registered the poorest birth outcomes in the industrialized world. The numbers haveworsened during the past 25 years even as they've improved in most of the world, largely because of the disproportionate toll on African Americans.
California has led the effort to reverse that trend, cutting its maternal death rate by 55% between 2006 and 2013, though the disparity for Black mothers has persisted.
Researchers have documented countless instances of pregnant African American women being ignored, drug-tested without permission, or sutured without pain medication.
There is a growing consensus among medical researchers and social scientists that discriminationcan result in toxic stress that causes maternal complications or premature births. Respectful, holistic prenatal care can improve outcomes, said Jennie Joseph, a British-trained midwife. Her prenatal clinic in Florida serving mostly low-income women of color has had consistently low rates of maternal complications and premature and low-birth-weight babies.
Joseph believes it matters less where a woman gives birth than how she is treated during the previous nine months, and most of her clients deliver in hospitals.
Groups like Amani's are encouraging more midwives of color to penetrate what she calls the profession's "old girls' network." Just 2% of American midwives are Black, and researchhas shown that Black patients tend to do better with Black providers.
There is evidence that their numbers are growing with demand, however. California now has about half a dozen licensed Black midwifery practices, including three that have opened in the San Francisco Bay Area since 2017.
Camara said she wanted to support them: She's had supportive, competent white birth attendants in the past, "but it wasn't the same," she said. "This is returning to what we did before."
At around 6 on a Saturday morning in mid-August, as a heat wave gripped the Bay Area, she phoned Jordan to tell her she was having contractions. Barely two hours later, the midwives helped her give birth to her son, Esangu, 8 pounds, 6 ounces, on her hands and knees on her living room floor.
Victor Coronado felt lightheaded one morning last month when he stood up to grab an iced tea. The right side of his body suddenly felt heavy. He heard himself slur his words. "That's when I knew I was going to have a stroke," he said.
Coronado was rushed to Mercy Hospital & Medical Center, the hospital nearest his home on Chicago's South Side. Doctors there pumped medicine into his veins to break up the clot that had traveled to his brain.
Coronado may outlive the hospital that saved him. Founded 168 years ago as the city's first hospital, Mercy survived the Great Chicago Fire of 1871 but is succumbing to modern economics, which have underfinanced the hospitals serving the poor. In July, the 412-bed hospital informed state regulators it planned to shutter all inpatient services as soon as February.
"If something else happens, who is to say if the responders can get my husband to the nearest hospital?" said Coronado's wife, Sallie.
While rural hospitals have been closing at a quickening pace over the past two decades, a number of inner-city hospitals now face a similar fate. And experts fear that the economic damage inflicted by the COVID-19 pandemic on safety-net hospitals and the ailing finances of the cities and states that subsidize them are helping push some urban hospitals over the edge.
By the nature of their mission, safety-net hospitals, wherever they are, struggle because they treat a large share of patients who are uninsured — and can't pay bills — or are covered by Medicaid, whose payments don't cover costs. But metropolitan hospitals confront additional threats beyond what rural hospitals do. State-of-the-art hospitals in affluent city neighborhoods are luring more of the safety-net hospitals' best-insured patients.
These combined financial pressures have been exacerbated by the pandemic at a time their role has become more important: Their core patients — the poor and people of color — have been disproportionately stricken by COVID-19 in metropolitan regions like Chicago.
"We've had three hospital closures in the last year or so, all of them Black neighborhoods," said Dr. David Ansell, senior vice president for community health equity at Rush University Medical Center, a teaching hospital on Chicago's West Side. He said the decision to close Mercy "is really criminal in my mind, because people will die as a result."
Mercy is following the same lethal path as did two other hospitals with largely lower-income patient bases that shuttered last year: Hahnemann University Hospital in Philadelphia, and Providence Hospital in Washington, D.C., which ended its inpatient services. Washington's only public hospital, United Medical Center — in the city's poorest ward — is slated to close in 2023 as well, and some services are already curtailed.
Slow Death of Urban Safety Nets
So far, urban hospital closures have remained infrequent compared with the cascading disappearance of their rural counterparts. But the closing of a few could portend problems at others. Even some of those that remain open may cut back crucial specialties like labor and delivery services or trauma care, forcing patients to travel farther for help when minutes can matter.
Nancy Kane, an adjunct professor at Harvard T.H. Chan School of Public Health who has studied urban safety-net hospital changes since 2010, said that "some close, but most of them have tried to get into a bigger system and hang on for a few more years until management closes them."
For much of the 20th century, most cities ran their own hospitals to care for the indigent. But after the creation of Medicare and Medicaid, and as the rising cost of healthcare became a burden for local budgets, many jurisdictions turned away from that model. Today only 498 of 5,230 general hospitals in the country are owned by governments or a public hospital district.
Instead, many hospitals in low-income urban neighborhoods are run by nonprofits — often faith-based — and in some cases, for-profit corporations. In recent years owners have unloaded safety-net hospitals to entities with limited patience for keeping them alive.
In 2018, the for-profit hospital chain Tenet Healthcare Corp. sold Hahnemann to Joel Freedman, a California private equity investor, for $170 million. A year later, Freedman filed for bankruptcy on the hospital, saying its losses were insurmountable, while separating its real estate, including the physical building, into another corporation, which could ease its sale to developers.
In 2018, Tenet sold another safety-net hospital, Westlake Hospital in Melrose Park, Illinois, a suburb west of Chicago, to a private investment company. Two weeks after the sale, the firm announcedit would close the hospital, which ultimately led the owners to pay Melrose Park $1.5 million to settle a lawsuit alleging they had misled local officials by claiming before the sale they would keep it open.
Some government-run hospitals are also struggling to stay open. Hoping to stem losses, the District of Columbia outsourced management of United Medical Center to private consulting firms. But far from turning the hospital around, one firm was accused of misusing taxpayer funds, and it oversaw a string of serious patient safety incidents, including violations in its obstetrics ward so egregious that the district was forced to shut the ward down in 2017.
Earlier this year, the district struck a deal with Universal Health Services, a Fortune 500 company with 400 hospitals and $11 billion in revenues, to run a new hospital that would replace United, albeit with a third fewer beds. Universal also operates George Washington University Hospital in the city in partnership with George Washington University. That relationship has been contentious: Last year the university accused the company of diverting $100 million that should have stayed in the medical system. In June, a judge dismissed most of the university's complaint.
No Saviors for Mercy
Chicago has three publicly owned hospitals, but much of the care for low-income patients falls on private safety-net hospitals like Mercy that are near their homes and have strong reputations. These hospitals have been sources of civic pride as well as major providers of jobs in neighborhoods that have few.
Fifty-five percent of Chicagoans living in poverty and 62% of its African American residents live within Mercy's service area, according to Mercy's 2019 community needs assessment, a federally mandated report. The neighborhoods served by Mercy are distinguished by higher rates of death from diabetes, cancer and stroke. Babies are more likely to be born early and at low weight or die in infancy. The nearest hospitals from Mercy can be 15 minutes or more away by car, and many residents don't have cars.
"You're going to have this big gap of about 7 miles where there's no hospital," Ansell said. "It creates a healthcare desert on the South Side."
Dr. Maya Rolfe, who was a resident at Mercy until July, said the loss of the hospital's labor and delivery department would cause substantial harm, especially since African American women suffer from a higher rate of maternal mortality than do white women. "Mercy serves a lot of high-risk women," she said.
Mercy, a nonprofit, has been in financial trouble for a while. In 2012, it joined Trinity Health, a giant nonprofit Roman Catholic health system headquartered in Michigan with operations in 22 states. In the next seven years, Trinity invested $124 million in infrastructure improvements and $112 million in financial support.
During that time, the hospital continued to be battered by headwinds facing hospitals everywhere, including the migration of well-reimbursed surgeries and procedures to outpatient settings. Likewise, patients with private insurance, which provides higher reimbursements than government programs do, departed to Chicago's better-capitalized university hospitals, including Rush, the University of Chicago Medical Center and Northwestern Memorial Hospital. Seventy-five percent of Mercy's revenues come from government insurance programs Medicare and Medicaid.
Only 42% of its beds were occupied on average, according to the most recent state data, from 2018. Mercy told state regulators it is losing $4 million a month and required at least $100 million in additional building upgrades to operate safely.
Trinity said it spent more than a year shopping for a buyer. After that yielded no success, Mercy joined forces with three other struggling South Side hospitals to consolidate into a single health system planning to build one hospital and a handful of outpatient facilities to replace their antiquated buildings. They sought state financial help.
The plan would have cost $1.1 billion over a decade. At the close of the legislative session, Illinois lawmakers — already strapped for funding because of the economic effects of the pandemic — balked at the hospitals' request for the state to cover half the cost. Lamont Robinson, a Democratic state representative whose district includes Mercy Hospital, said that was because the group did not declare where the new hospital would be built.
"We were all supportive of the merger but not with the lack of information," Robinson said.
Mercy said in an email that the location would have been chosen after the hospital organizations combined and chose new leaders. Trinity said in a statement: "We are committed to continuing to serve the Mercy Chicago community through investment in additional ambulatory and community-based services that are driven by high-priority community needs."
Blame for Mercy's closure has been spread widely to include the city and state governments as well as Mercy's owner. Trinity Health had $8.8 billion in cash and liquid investments at the end of March and until the pandemic hit had been running a slight profit. Earlier this year in Philadelphia, Trinity Health announced it would phase out inpatient services at another of its safety-net hospitals, Mercy Catholic Medical Center-Mercy Philadelphia Campus, a 157-bed hospital that has been around since 1918.
"People put their money where they want to," said Rolfe, the former medical resident at Mercy in Chicago. Noting that the city has no qualms about spending large sums to beautify its downtown while other neighborhoods are in danger of losing a major institution, she said: "It shows to me that those patients are not that important as patients that exist in other communities."
So far, participation by minority volunteers in coronavirus trials has increased only slightly compared with typically low levels for other clinical trials — and targeted outreach efforts to recruit more minorities have been slow to launch.
This article was published on Wednesday, September 16, 2020 in Kaiser Health News.
Participation in clinical trials among Black people is low, according to Food and Drug Administration statistics. Still, including them in coronavirus vaccine trials has been a stated priority for the pharmaceutical companies involved, since African American communities, along with those of Latinos, have suffered disproportionately from the pandemic.
The ongoing trials are moving at a pace that is unprecedentedfor medical research, with the Trump administration's vaccine acceleration effort dubbed "Operation Warp Speed." Yet recruiting minority participants requires sensitivity to a mistrust borne of past and current medical mistreatment. Trust-building cannot be rushed.
So far, participation by minority volunteers in coronavirus trials has increased only slightly compared with typically low levels for other clinical trials — and targeted outreach efforts to recruit more minorities have been slow to launch.
Some of that outreach is taking place at historically black colleges and universities, which are trusted institutions for many Black Americans. At Meharry Medical College in Nashville, Tennessee, researchers have set up in-person meetings with patients they already know. Earlier this month, a half-dozen patients gathered in a cramped conference room on campus. They snacked on turkey sandwiches and potato chips and listened to the pitch from their physician, Dr. Vladimir Berthaud.
"What's the best hope to get rid of this virus?" he asked them.
"Vaccination," they replied.
Then Berthaud followed up: "So raise your hand if you would like to take the vaccine?"
Some hands shot up, but not all.
"I ain't going to be the first one, now," said Lanette Hayes.
Katrina Thompson said she does eventually want to get a shot for protection against the coronavirus. She explained she's especially worried about all the residents of her apartment building who don't seem to be doing the basics of covering their coughs.
"The word 'vaccination' don't scare me," she said. "The word 'trial' do."
Black Americans have reason to be suspicious — stemming beyond the well-known Tuskegee experiments, in which Black men with syphilis were deceived and mistreated as part of an experiment that went on for decades. Many Black Americans report ongoing mistreatment by medical providers today.
Berthaud is recruiting patients for a clinical trial site he will oversee in Nashville, and he would like more than 300 people of color to enroll. Berthaud, who is Black and from Haiti, appeals to his patients' sense of duty.
"If you don't have enough people like you in those vaccine trials, you will not know if it works for you," he told them. "You will not know."
For most of the current coronavirus vaccine trials, recruitment mainly takes place online — which often results in mostly white people enrolling.
That's why Meharry researchers are wooing Black patients with a personal invitation. But they're not recruiting for the phase 3 trials underway. Meharry's first trial, for a vaccine candidate by Novavax, doesn't launch until October.
Other pharmaceutical companies are nearly done recruiting. Moderna said it chose nearly 100 trial sites for their "representative demography."
The company did not respond to requests for comment but publicizes demographic statistics about the clinical volunteers every week. While somewhat more inclusive than the typical clinical trial, it still is not a good representation of the diversity of the U.S.
For the coronavirus vaccine in particular, the National Institutes of Health has suggested minorities should be overrepresented in testing — perhaps at rates that are double their percentage of the U.S. population.
"We say we want to have everybody included, but really the effort for the vaccinations — in a sense — [is] starting the same way they've always been," said Dr. Dominic Mack, of Morehouse School of Medicine in Atlanta.
He's working with the NIH to make sure people of color are included in COVID-19 research. Mack said there are no shortcuts if medical research is going to reflect the diversity of the U.S. It takes time to build trust and meaningful relationships with people who have endured a history of abuse or neglect by medical providers, and exclusion from biomedical research and decision-making.
"Now, that being said, the only thing we can do is what we're doing," he said — by which he means respectful, unrushed outreach and dialogue.
The primary effort, called theCOVID-19 Prevention Network, taps into four existing clinical trial networks designed to advance HIV research. Those networks are based in Seattle, Atlanta, Los Angeles and Durham, North Carolina.
One project will be led by the Rev. Edwin Sanders II of the Metropolitan Interdenominational Church in Nashville. It will involve seven "faith ambassadors" and 30 "clergy consultants" in the African American community working to dispel myths and increase trust in the clinical trial process. But Sanders cautioned this is not about a hard sell. It's not his job to preach trial participation from the pulpit, he said.
"We are not out beating the drum," he said, acknowledging that congregants may have legitimate concerns. "I am not going to do anything more than make sure people are able to make an informed choice."
The danger in lunging for big diversity goals is that it could spark a backlash, meaning minorities might be even less willing to participate, said associate professor Rachel Hardeman, who studies health equity at the University of Minnesota. It's important that the doctors doing the asking look like the people they're appealing to, she said.
"It's racial concordance," she explained. "It offers this feeling of, 'You know who I am, you know where I come from, you have my best interests at heart.'"
Historically Black medical institutions in the U.S. are uniquely positioned to do this work. While they haven't been on the leading edge of recruitment for vaccine trials, they intend to play an important part. The president of Nashville's Meharry Medical College, Dr. James Hildreth, is an infectious disease researcher. But instead of overseeing the trial site being hosted on his campus, Hildreth has a more modest goal in mind: He plans to participate as a patient, and urge others to join him.
"I think my role is more important in advocating for people to be involved in vaccine studies than to be one of the leaders of the study," he said.
So at Meharry, Berthaud is the principal investigator. As lunch wraps up in the crowded conference room, he has managed to win over some holdouts.
"Where is the line?" asked Robert Smith. "Where do we sign?"
Smith, with his young grandson in tow, didn't raise his hand at first when asked if he'd take the vaccine. But after listening to Berthaud, Smith agreed to participate in the clinical trial — for no other reason than the trust he has in Berthaud, his longtime physician.
"He's not only my doctor; he's proven that he cares about me," Smith said.
Persuading hundreds or thousands of Black Americans to sign up will be difficult. But researchers hope their outreach efforts will at least result in more minorities agreeing to take an approved vaccine when available.
Up and down the West Coast, hospitals and health facilities are reporting an influx of patients with problems most likely related to smoke inhalation.
This article was published on Wednesday, September 16, 2020 in Kaiser Health News.
By Mark Kreidler The patients walk into Dr. Melissa Marshall's community clinics in Northern California with the telltale symptoms. They're having trouble breathing. It may even hurt to inhale. They've got a cough, and the sore throat is definitely there.
A straight case of COVID-19? Not so fast. This is wildfire country.
Up and down the West Coast, hospitals and health facilities are reporting an influx of patients with problems most likely related to smoke inhalation. As fires rage largely uncontrolled amid dry heat and high winds, smoke and ash are billowing and settling on coastal areas like San Francisco and cities and towns hundreds of miles inland as well, turning the sky orange or gray and making even ordinary breathing difficult.
But that, Marshall said, is only part of the challenge. Facilities already strapped for testing supplies and personal protective equipment must first rule out COVID-19 in these patients, because many of the symptoms they present with are the same as those caused by the virus.
"Obviously, there's overlap in the symptoms," said Marshall, the CEO of CommuniCare, a collection of six clinics in Yolo County, near Sacramento, that treats mostly underinsured and uninsured patients. "Any time someone comes in with even some of those symptoms, we ask ourselves, 'Is it COVID?' At the end of the day, clinically speaking, I still want to rule out the virus."
The protocol is to treat the symptoms, whatever their cause, while recommending that the patient quarantine until test results for the virus come back, she said.
It is a scene playing out in numerous hospitals. Administrators and physicians, finely attuned to COVID-19's ability to spread quickly and wreak havoc, simply won't take a chance when they recognize symptoms that could emanate from the virus.
"We've seen an increase in patients presenting to the emergency department with respiratory distress," said Dr. Nanette Mickiewicz, president and CEO of Dominican Hospital in Santa Cruz. "As this can also be a symptom of COVID-19, we're treating these patients as we would any person under investigation for coronavirus until we can rule them out through our screening process." During the workup, symptoms that are more specific to COVID-19, like fever, would become apparent.
For the workers at Dominican, the issue moved to the top of the list quickly. Santa Cruz and San Mateo counties have borne the brunt of the CZU Lightning Complex fires, which as of Sept. 10 had burned more than 86,000 acres, destroying 1,100 structures and threatening more than 7,600 others. Nearly a month after they began, the fires were approximately 84% contained, but thousands of people remained evacuated.
Dominican, a Dignity Health hospital, is "open, safe and providing care," Mickiewicz said. Multiple tents erected outside the building serve as an extension of its ER waiting room. They also are used to perform what has come to be understood as an essential role: separating those with symptoms of COVID-19 from those without.
At the two Solano County hospitals operated by NorthBay Healthcare, the path of some of the wildfires prompted officials to review their evacuation procedures, said spokesperson Steve Huddleston. They ultimately avoided the need to evacuate patients, and new ones arrived with COVID-like symptoms that may actually have been from smoke inhalation.
Huddleston said NorthBay's intake process "calls for anyone with COVID characteristics to be handled as [a] patient under investigation for COVID, which means they're separated, screened and managed by staff in special PPE." At the two hospitals, which have handled nearly 200 COVID cases so far, the protocol is well established.
Hospitals in California, though not under siege in most cases, are dealing with multiple issues they might typically face only sporadically. In Napa County, Adventist Health St. Helena hospital evacuated51 patients on a single August night as a fire approached, moving them to 10 other facilities according to their needs and bed space. After a 10-day closure, the hospital was allowed to reopen as evacuation orders were lifted, the fire having been contained some distance away.
The wildfires are also taking a personal toll on healthcare workers. CommuniCare's Marshall lost her family's home in rural Winters, along with 20 acres of olive trees and other plantings that surrounded it, in the Aug. 19 fires that swept through Solano County.
"They called it a 'firenado,'" Marshall said. An apparent confluence of three fires raged out of control, demolishing thousands of acres. With her family safely accounted for and temporary housing arranged by a friend, she returned to work. "Our clinics interact with a very vulnerable population," she said, "and this is a critical time for them."
While she pondered how her family would rebuild, the CEO was faced with another immediate crisis: the clinic's shortage of supplies. Last month, CommuniCare got down to 19 COVID test kits on hand, and ran so low on swabs "that we were literally turning to our veterinary friends for reinforcements," the doctor said. The clinic's COVID test results, meanwhile, were taking nearly two weeks to be returned from an overwhelmed outside lab, rendering contact tracing almost useless.
Those situations have been addressed, at least temporarily, Marshall said. But although the West Coast is in the most dangerous time of year for wildfires, generally September to December, another complication for health providers lies on the horizon: flu season.
The Southern Hemisphere, whose influenza trends during our summer months typically predict what's to come for the U.S., has had very little of the disease this year, presumably because of restricted travel, social distancing and face masks. But it's too early to be sure what the U.S. flu season will entail.
"You can start to see some cases of the flu in late October," said Marshall, "and the reality is that it's going to carry a number of characteristics that could also be symptomatic of COVID. And nothing changes: You have to rule it out, just to eliminate the risk."
More than 20 states either don't release or have incomplete data on the rapid antigen tests now considered key to containing the coronavirus, which has sickened more than 6 million Americans. The lapses leave officials and the public in the dark about the true scope of the pandemic as untold numbers of cases go uncounted.
The gap will only widen as tens of millions of antigen tests sweep the country. Federal officials are prioritizing the tests to quickly detect COVID-19's spread over slower, but more accurate, PCR tests.
Relying on patchy data on COVID testing carries enormous consequences as officials decide whether to reopen schools and businesses: Go back to normal too quickly and risk even greater outbreaks of disease. Keep people at home too long and risk an even greater economic crisis.
"The absence of information is a very dangerous thing," said Janet Hamilton, executive director of the Council for State and Territorial Epidemiologists, which represents public health officials. "We will be blind to the pandemic. It will be happening around us and we will have no data."
The states that don't report antigen test results or don't count antigen positives as COVID cases are California, Colorado, Georgia, Illinois, Maryland, Minnesota, Missouri, Montana, New Hampshire, New Jersey, North Carolina, North Dakota, Ohio, Pennsylvania, South Dakota, Tennessee, Texas, Vermont, Virginia, Washington, Wisconsin and Wyoming, as well as the District of Columbia.
So far, most of the COVID tests given in the U.S. have been PCR tests, which are processed in medical labs and can take days to return results. By contrast, antigen tests offer results in minutes outside of labs, appealing to everyone from medical clinics to sports teams and universities.
Each relies on swabs to test patients. But unlike using tests run through labs, many providers who would use antigen tests don't have an easy way to send data electronically to public health authorities.
Since July, though, the federal government has pushed roughly 5 million antigen tests into nearly 14,000 nursing homes to contain outbreaks among staff members and residents. The Department of Health and Human Services also awarded a $760 million contract to buy 150 million rapid antigen tests from Abbott, the Illinois-based diagnostics behemoth. It plans to send 750,000 of those to nursing homes starting this week, Brett Giroir, the HHS official heading the Trump administration's testing efforts, told industry executives on Sept. 8. Federal officials have not elaborated on how many tests will be sent elsewhere but have suggested many will go to governors to distribute as schools reopen.
The rush of antigen tests, however, won't be particularly useful to officials if the results are not publicly and uniformly reported.
KHN surveyed 50 states and the District of Columbia on their collection of antigen test results and what is reported publicly. Forty-eight responded between Sept. 3 and 10, revealing significant variation over whether people who test positive for COVID-19 with an antigen test are counted as cases and whether states even publicly report antigen data in their testing numbers:
21 states and D.C. do not report all antigen test results.
15 states and D.C. do not count positive results from antigen tests as COVID cases.
Two states do not require antigen test providers to report results, and five others require only positive results to be reported.
Nearly half of states believe their antigen test results are underreported.
Consequently, many state counts of infected people could be artificially low. For instance, the lack of reporting could imply infection rates are declining because the virus isn't spreading as widely — when really more antigen tests are being used and not counted, public health officials and experts say.
"It's going to look like your cases are coming down when they're not," said Jeffrey Morris, a biostatistics professor at the University of Pennsylvania.
HHS recognizes that antigen tests are underreported but maintained that officials are not missing the full scale of the pandemic, an agency spokesperson said.
"There is sufficient testing to achieve all objectives outlined in the testing strategy, including identifying newly emergent outbreaks, supporting public health isolation and contact tracing, protecting the vulnerable, supporting safe reopening of schools and businesses, and enabling state testing plans," spokesperson Mia Heck said.
Part of the problem on antigen test reporting stems from what counts as a COVID case. Guidance from the Centers for Disease Control and Prevention defines a "confirmed" COVID case as one that is determined from a PCR test. Positive results from antigen tests are considered "probable" cases because the tests can be less accurate.
Months after the first COVID antigen test received emergency authorization from the Food and Drug Administration, the CDC revised its COVID case definition in early August to allow a positive antigen test to count as a probable case without assessing whether a person had clinical symptoms or was in close contact with a confirmed infected person.
That prompted many states — including Arkansas, starting Sept. 2 — to adjust how they report cases.
"It's easy for people to think since we use the word 'probable' that maybe it's a case, maybe it isn't. But that's not how we think of it," said Dr. Jennifer Dillaha, medical director for the Arkansas Department of Health. "It is a real case in the same way that a PCR is a real case."
Dr. Karen Landers, an assistant state health officer for the Alabama Department of Public Health, said her biggest concern was the potential undercounting of antigen test results as they continue to grow in popularity. While the state has been trying to work with each urgent care or other medical provider, some struggle to submit the results.
"We can't afford to miss a case," she said.
The CARES Act, which Congress passed in March, requires a broad range of healthcare providers to report any COVID test result to state or local health departments. Nonetheless, two states — Montana and New Jersey — said they weren't requiring antigen test providers to report results, positive or negative. Colorado, Maine, Mississippi, New Hampshire and Wyoming require only positive results to be reported, which can distort the positivity rate.
Sara Mendez, the support services manager for the Brazos County Health Department in Texas, said the department saw an increase of antigen tests being administered as Texas A&M University students returned. Even though the state health department was not including positive COVID cases from antigen tests in its public reports, the local health department felt obligated to do so.
"A lot of the college students will just go and get those done as opposed to the PCR tests," Mendez said, "so we felt like we were missing out."
Indiana University undertook a massive antigen testing operation for students living on campus in August, administering 14,870 antigen tests across four campuses through drive-thrus, according to Graham McKeen, an assistant university director for public health. The test results were delivered while students waited in cars for about 30 minutes, with 159 coming back positive. Each night, a university staff member would manually download the spreadsheet off each of the test machines and securely email it to the state health department.
But Indiana began reporting antigen testing only on Aug. 24, adding over 16,000 antigen tests into its public dashboard that day and saying in a news release that it plans to retroactively add in earlier antigen testing figures.
McKeen said that, even though the state is now reporting some antigen data, tests are still missed under the cumbersome reporting system. The state said some of the data is being sent by fax.
"It doesn't give the community a good handle on the infection in the community," McKeen said.
Heck, the HHS spokesperson, said that federal agencies are working to improve the reporting of results and that problems were likely to be eased in the future, citing that Abbott's antigen test includes an electronic reader for automated reporting. By October, 48 million of those tests will be in circulation each month, she said.
Still, to date, "what this is exposing is the antiquated systems that public health agencies have had for years," said Scott Becker, executive director of the Association of Public Health Laboratories. "So much of the data we've gotten is incomplete."
That data barrier is playing out in nursing homes as well.
Victoria Crenshaw is holding off on using antigen tests to screen residents and staff members at Westminster Canterbury on Chesapeake Bay nursing home in Virginia Beach, Virginia. As senior director, she sees one major holdup: No technology platform is in place to easily send results to health officials. Instead, she and colleagues would need to resort to taping pieces of paper together to deliver details of who was tested, and hope local officials would accept it.
The Trump administration is pushing for nursing homes to use the tests for required screenings at least once a month and as often as twice a week. Under new federal regulations, nursing homes that don't comply with regular testing and reporting requirements are subject to citations or fines.
"We have no technology today to submit this information," Crenshaw said, "which leaves us in a vulnerable position."
Before the coronavirus pandemic shut down the entertainment industry in March,Jeffrey Farber had a steady flow of day jobs in film and television, including work on "Hunters" and "Blue Bloods." But when theaters, movies and TV shows stopped production, not only did Farber lose his acting income, he also stopped accruing the hours and earnings he needed to qualify for health insurance through his labor union, SAG-AFTRA.
Without the acting jobs, his insurance would be ending this month.
"This is an unbelievable situation," said Farber, 65, a survivor of pancreatic cancer. "There are going to be so many people who aren't going to be able to make it."
From Broadway to Hollywood, many actors, directors, backstage workers, musicians and others in the performing arts face similar coverage suspensions. Those in the entertainment industry often have several employers over the course of a year as they move from show to show. In some ways, they're quintessential gig workers.
Their employers generally make financial contributions to a benefit fund under the terms of the union contract. And the workers pay premiums on their coverage. If workers accumulate a predetermined number of hours or earnings, they can qualify for coverage for up to a year. Coverage is typically comprehensive and quite inexpensive. Farber paid just $408 every three months to cover him and his husband.
It's a model some academics think might work for others in the gig economy. "It makes coverage possible in industries like retail, construction and entertainment where it might not otherwise be offered," said JoAnn Volk, a research professor at Georgetown University's Center on Health Insurance Reforms.
As the COVID pandemic period has shown, it doesn't always work well. Someone in the entertainment industry may be able to weather a dry spell without any work because he's already qualified for coverage based on past employment. But once coverage lapses, this system could leave entertainers at a disadvantage over other workers returning to a more conventional job, where coverage can start immediately. Plus, members may continue to owe union dues, even though they aren't eligible for health benefits.
The timing of the shutdown couldn't be worse for Farber, who needed just 12 days of work or $249 in earnings by the end of June to qualify for continued coverage in October. Accumulating that would have been "easy as pie," he said.
In the entertainment unions' benefit plans, "coverage is always prospective," said Phyllis Borzi, a former assistant secretary in the Department of Labor who headed the Employee Benefits Security Administration and is now a consultant. "That works fine if you have a short interruption, but they've been out so long, to the extent they have hours banked, they must be out of them by now."
SAG-AFTRA represents about 160,000 professionals in TV, radio, film and other media. The union requires that members this year generally must accumulate at least 84 days of qualifying work or earn $18,040 over four quarters to be eligible for coverage for the next four quarters.
Farber eventually got a temporary reprieve because he learned he could qualify for coverage with lower earnings under a separate category for people who are least 40 years old and have 10 or more years of health plan eligibility. But he doesn't know how coverage changes planned for next year will affect his eligibility.
The health plan has taken some steps to alleviate concerns raised by members. In April, it cut healthcare premiums in half for the second quarter and this month announced a temporary reductionof COBRA premiums for some members.
The SAG-AFTRA benefit fund didn't respond to requests for comment.
Even in the best of times, it can be difficult for those in the entertainment industry whose names appear in small print in the credits to string together enough work to qualify for coverage. If social restrictions were to ease and people could get work heading into fall, any accumulated hours and income may be too far in the past to count toward future coverage, leaving them no choice but to start accumulating them all over again.
In contrast, when employers hire someone eligible for on-the-job coverage, they typicallycan't impose waiting periods longer than 90 days for health insurance under the Affordable Care Act.
Like people who work for a single employer, workers who lose coverage through their union benefit plan can continue their coverage for up to 18 months under federal COBRA law, but workers who make that choice generally have to pick up the entire cost of the plan. And COBRA coverage is not cheap. They may also enroll in a plan on their state marketplace set up by the Affordable Care Act or, if they qualify, in Medicaid, the federal-state program for low-income people.
When the pandemic hit in mid-March, Dee Nichols had logged 512 of the 600 hours he needed to accumulate in a six-month period to qualify for health coverage with the Motion Picture Industry health plan.
Nichols, a camera operator in Los Angeles who is a member of Local 600 of the International Cinematographers Guild, had two shows lined up in early March that would have brought him up to the threshold by March 21, the end of his qualifying period for coverage. Then production was canceled.
It wasn't the first time that Nichols, 49, had missed the hours target for coverage through his union plan. "You're trying to fill a tub of water and it keeps getting holes," Nichols said. Meanwhile, he pays $400 a month for an individual marketplace plan with a $6,000 deductible. "They're fine with guys like me contributing and then not being able to pull [benefits] out of it," he said. "It drives me insane."
The Motion Picture Industry health plan also offered some relief to members, including extending them some hours of credit, waiving premiums for dependents and offering COBRA subsidies.
But the assistance didn't help Nichols qualify for coverage.
He and another member are part of a class action lawsuit arguing that the health plan has a responsibility under federal law to treat all plan participants equally.
The health plan didn't respond to a request for comment.
Unclear When 'We'll Work Again'
To assist its members during the pandemic, the Actors' Equity Association health plan waived premiums for three months starting in May and is temporarily offering a lower-cost plan through the end of the year.
But since these multi-employer plans are self-funded, they pay members' claims directly. That can cause problems when work is scant and employers aren't paying into the fund.
"All of these health funds have different financial positions, and they have to maintain reserves in order to maintain coverage for their members," said Brandon Lorenz, communications director of the Actors' Equity Association, which represents approximately 52,000 actors and stage managers.
SAG-AFTRA, which has projected a $141 million deficit in its health plan this year, announced far-reaching changes to coverage for next year, including higher thresholds on earnings and days worked to qualify for coverage.
That could prove an added challenge for Jeffrey Farber, who is concerned about what job opportunities will be available when the industry recovers.
"None of us knows when production is going to start again or if we'll work again," he said.
The staff at Stony Brook Southampton Hospital is accustomed to the number of patients tripling or even quadrupling each summer when wealthy Manhattanites flee the city for the Hamptons. But this year, the COVID pandemic has upended everything.
The 125-bed hospital on the southern coast of Long Island has seen a huge upswing in demand for obstetrics and delivery services. The pandemic has families who once planned to deliver babies in New York or other big cities migrating to the Hamptons for the near term.
From the shores of Long Island to the resorts of the Rocky Mountains, traditional vacation destinations have seen a major influx of affluent people relocating to wait out the pandemic. But now as summer vacation season has ended, many families realize that working from home and attending school online can be done anywhere they can tether to the internet, and those with means are increasingly waiting it out in the poshest destinations.
Many of the medical facilities in these getaway spots are used to seeing summer visitors for bug bites or tetanus shots, hiring an army of temporary doctors to get through the summer swells. Now they face the possibility of needing to treat much more serious medical conditions into the fall months — and for the foreseeable future.
Such increase in demand could strain or even overwhelm the more remote towns' hospitals and healthcare providers, threatening the availability of timely care for both the newcomers and the locals. The Southampton hospital has just seven intensive care unit beds, with the capacity to expand to as many as 30, but it wouldn't take much for the hospital to be swamped by patients.
"For healthcare, the bottom line is: As our population grows, we have to have the infrastructure to support it," said Tamara Pogue, CEO of Peak Health Alliance, a nonprofit community health insurance-purchasing cooperative in Colorado ski country.
And many communities do not.
Home Sales Soar
Sunny shores and mountain vistas are prompting people to relocate to second homes if they have them, or to purchase new homes in those areas if they don't. Renters who used to come for a month are now staying for two or three, and summer renters are becoming buyers. Multimillion-dollar residences in the ski resort town of Aspen, Colorado, for example, that once sat on the market for nearly a year now move in weeks.
"Some of the most experienced and seasoned real estate brokers have never seen activity like what we have experienced in July and August," said Tim Estin, a broker in Aspen, whose firm draws clients from COVID hot spots such as Dallas, Houston, New York, Miami, Los Angeles and Chicago.
Many destinations tried to discourage second-home owners from coming, particularly early in the pandemic after Colorado ski resorts became an epicenter of COVID cases. Gunnison County, Colorado, home to the Crested Butte ski resort,banned out-of-towners, prompting the Texas attorney general to take up the matter on behalf of Texans with homes in the area. In Lake Tahoe, along the California-Nevada border, second-home owners were told to go back to the Bay Area. And in New York vacation destinations, online messages targeted big-city transplants with classic New York aplomb.
The ski resort town of Vail, Colorado, on the other hand, welcomed them with open arms with its Welcome Home Neighbor campaign in May.
"We have long held the belief that in a resort community with so many second homes, that lights on are good, lights off are bad," said Chris Romer, president and CEO of the Vail Valley Partnership, the region's chamber of commerce.
Romer said the 56-bed Vail Health Hospital supported the campaign, particularly after visits to the town plummeted 90% in April once the ski lifts stopped running.
"We never would have launched the program if the hospital didn't sign off on it," Romer said.
Demand for Healthcare
The influx of patients to these rural areas is helping hospitals and clinics rebound from the drop in typical patient visits during the pandemic, but there is concern that additional growth could overwhelm local resources. So far, though, enough people seem reluctant to seek care during the pandemic, unless it's an emergency or COVID-related, that it hasn't reached a tipping point. Others might be seeking care with their providers in the big city through telehealth or the occasional run back to their primary residence. But the mix of patients is different.
In Leadville, Colorado, a town nestled in the mountains at an altitude of 10,151 feet, summertime usually means an influx of mountain bikers and runners.
"Leadville has these crazy 100-mile races, where we have very elite athletes from all over the planet, and they have specific medical needs," said Dr. Lisa Zwerdlinger, chief medical officer at the local St. Vincent Hospital. "But what we're seeing now are these second-home owners, people who are coming from other places to spend extended periods of time in Leadville and who come with a whole host of other medical issues."
Most of the races this summer were canceled. That meant fewer extreme athletes and more Texans; fewer broken bones and turned ankles, and more chronic conditions exacerbated by the high altitude. Nonetheless, August was the busiest month ever at Zwerdlinger's family medicine practice.
Hospitals in vacation towns typically prepare for surges during holidays, said Jason Cleckler, CEO of Middle Park Health, with locations serving Colorado's Winter Park and Granby Ranch ski resorts in Grand County. During Christmas week, the population of neighboring Summit County, which houses resorts like Breckenridge and Keystone, swells from 31,000 to 250,000. But Cleckler said the COVID surge in resort communities is drawn-out so hospitals may have to respond with more permanent increases in capacity.
In Big Sky, Montana, whose part-time residents include Bill Gates and Justin Timberlake, Big Sky Medical Center doubled its capacity to eight beds in anticipation of a surge in patients due to COVID-19. The center's two primary care doctors are completely booked. With so many new people in town, the hospital has accelerated plans to shift a third full-time doctor into the clinic.
As the wily coronavirus works its way into all corners of America, though, patients may find that not all regions have the same capacity to deal with COVID or even other complex medical problems.
Visitors to the sole clinic in nearby West Yellowstone, a gateway to the namesake national park, expect to be able to get COVID tests even if they have no symptoms or a known connection to a case, said Community Health Partners spokesperson Buck Taylor.
"There seems to be a frustration that a rural Montana clinic doesn't have the resources they expect at home," Taylor said. "That's nothing new. People come to Montana all the time and say, 'But where can I get any good Thai food?'"
Planning for What's Next
The year has been such an outlier for hospitals that it's difficult for them to predict and plan for what will happen next. On Long Island, many locals typically leave the Hamptons for Florida during the winter. But it's unclear whether those snowbirds will stay or go this year, given the high levels of COVID-19 in Florida now, said Robert Chaloner, CEO of Stony Brook Southampton. That could also change the demand for who needs medical care.
One indication that some visitors may be staying put? The jump in new students. The Big Sky school district expects a 20% increase in enrollment this fall. Leadville schools have at least 40 new students. Vail Mountain School's waiting list is its longest ever.
Many have speculated that the pandemic lockdown might fundamentally change the way companies operate, allowing more people to work from distant locations for the foreseeable future.
"Every indicator that I see is pointing to the fact that this is a shift," said Romer in Vail. "It has the potential to be permanent."
Taylor Rose, Big Sky Medical Center's director of operations and clinical services, said that, if that happens, the hospital will have to rebalance its services.
"I'd probably give it a year or two before I make any major changes," Rose said. "People are going to start deciding, 'This really isn't for me. I'm not going to stay here and deal with 6 feet of snow in the winter.'"
AstraZeneca, which is running the global trial of the vaccine it produced with Oxford University, said the trial volunteer recovered from a severe inflammation of the spinal cord and is no longer hospitalized.
This article was published on Tuesday, September 15, 2020 inKaiser Health News.
By Arthur Allen and Liz Szabo The Food and Drug Administration is weighing whether to follow British regulators in resuming a coronavirus vaccine trial that was halted when a participant suffered spinal cord damage, even as the National Institutes of Health has launched an investigation of the case.
"The highest levels of NIH are very concerned," said Dr. Avindra Nath, intramural clinical director and a leader of viral research at the National Institute for Neurological Disorders and Stroke, an NIH division. "Everyone's hopes are on a vaccine, and if you have a major complication the whole thing could get derailed."
A great deal of uncertainty remains about what happened to the unnamed patient, to the frustration of those avidly following the progress of vaccine testing. AstraZeneca, which is running the global trial of the vaccine it produced with Oxford University, said the trial volunteer recovered from a severe inflammation of the spinal cord and is no longer hospitalized.
AstraZeneca has not confirmed that the patient was afflicted with transverse myelitis, but Nath and another neurologist said they understood this to be the case. Transverse myelitis produces a set of symptoms involving inflammation along the spinal cord that can cause pain, muscle weakness and paralysis. Britain's regulatory body, the Medicines and Healthcare Products Regulatory Agency, reviewed the case and has allowed the trial to resume in the United Kingdom.
AstraZeneca "need[s] to be more forthcoming with a potential complication of a vaccine which will eventually be given to millions of people," said Nath. "We would like to see how we can help, but the lack of information makes it difficult to do so."
Any decision about whether to continue the trial is complex because it's difficult to assess the cause of a rare injury that occurs during a vaccine trial — and because scientists and authorities have to weigh the risk of uncommon side effects against a vaccine that might curb the pandemic.
"So many factors go into these decisions," Nath said. "I'm sure everything is on the table. The last thing you want to do is hurt healthy people."
The NIH has yet to get tissue or blood samples from the British patient, and its investigation is "in the planning stages," Nath said. U.S. scientists could look at samples from other vaccinated patients to see whether any of the antibodies they generated in response to the coronavirus also attack brain or spinal cord tissue.
Such studies might take a month or two, he said. The FDA declined to comment on how long it would take before it decides whether to move forward.
Dr. Jesse Goodman, a Georgetown University professor and physician who was chief scientist and lead vaccine regulator at the FDA during the Obama administration, said the agency will review the data and possibly consult with British regulators before allowing resumption of the U.S. study, which had just begun when the injury was reported. Two other coronavirus vaccines are also in late-stage trials in the U.S.
If it determines the injury in the British trial was caused by the vaccine, the FDA could pause the trial. If it allows it to resume, regulators and scientists surely will be on the watch for similar symptoms in other trial participants.
A volunteer in an earlier phase of the AstraZeneca trial experienced a similar side effect, but investigators discovered she had multiple sclerosis that was unrelated to the vaccination, according to Dr. Elliot Frohman, director of the Multiple Sclerosis & Neuroimmunology Center at the University of Texas.
Neurologists who study illnesses like transverse myelitis say they are rare — occurring at a rate of perhaps 1 in 250,000 people — and strike most often as a result of the body's immune response to a virus. Less frequently, such episodes have also been linked to vaccines.
The precise cause of the disease is key to the decision by authorities whether to resume the trial. Sometimes an underlying medical condition is "unmasked" by a person's immune response to the vaccine, leading to illness, as happened with the MS patient. In that case, the trial might be continued without fear, because the illness was not specific to the vaccine.
More worrisome is a phenomenon called "molecular mimicry." In such cases, some small piece of the vaccine may be similar to tissue in the brain or spinal cord, resulting in an immune attack on that tissue in response to a vaccine component. Should that be the case, another occurrence of transverse myelitis would be likely if the trial resumed, said Dr. William Schaffner, an infectious disease specialist at the Vanderbilt University School of Medicine. A second case would shut down the trial, he said.
In 1976, a massive swine flu vaccination program was halted when doctors began diagnosing a similar disorder, Guillain-Barré syndrome, in people who received the vaccine. At the time no one knew how common GBS was, so it was difficult to tell whether the episodes were related to the vaccine.
"It's very, very hard" to determine if one rare event was caused by a vaccine, Schaffner said. "How do you attribute an increased risk for something that occurs in one in a million people?"
Before allowing U.S. trials to restart, the FDA will want to see why the company and an independent data and safety monitoring board (DSMB) in the U.K. felt it was safe to continue, Goodman said. The AstraZeneca trial in the United States has a separate safety board.
FDA officials will need to review full details of the case and may request more information about the affected study volunteer before deciding whether to allow the U.S. trial to continue, Goodman said. They may also require AstraZeneca to update the safety information it provides to study participants.
It's possible that the volunteer's health problem was a coincidence unrelated to the vaccine, said Dr. Amesh Adalja, a senior scholar at the Johns Hopkins Center for Health Security. Studies aren't usually stopped over a single health problem, even if it's serious.
Yet many health leaders have expressed frustration that AstraZeneca hasn't released more information about the health problem that led it to halt its U.K. trial.
"There is just so little information about this that it's impossible to understand what the diagnosis was or why the DSMB and sponsor were reassured" that it was safe to continue, Goodman said.
AstraZeneca has said it's unable to provide more information about the health problem, saying this would violate patient privacy, although it didn't say how.
But there's an exceptional need for transparency in a political climate rife with vaccine hesitancy and mistrust of the Trump administration's handling of the COVID-19 response, leading scientists say.
"While I respect the critical need for patient confidentiality, I think it would be really helpful to know what their assessment of these issues was," Goodman said. "What was the diagnosis? If there wasn't a clear diagnosis, what is it that led them to feel the trial could be restarted? There is so much interest and potential concern about a COVID-19 vaccine that the more information that can be provided, the more reassuring that would be."
The FDA will need to balance any possible risks from an experimental vaccine with the danger posed by COVID-19, which has killed nearly 200,000 Americans.
"There are also potential consequences if you stop a study," Goodman said.
If the AstraZeneca vaccine fails, the U.S. government is supporting six other COVID vaccines in the hope at least one will succeed. The potential problems with the AstraZeneca vaccine show this to be a wise investment, Adalja said.
"This is part of the idea of not having just one vaccine candidate going forward," he said. "It gives you a little more insurance."
Schaffner said researchers need to remember that vaccine research is unpredictable.
"The investigators have inadvisedly been hyping their own vaccine," Schaffner said. "The Oxford investigators were out there this summer saying, 'We're going to get there first.' But this is exactly the sort of reason … Dr. [Anthony] Fauci and the rest of us have been saying, 'You never know what will happen once you get into large-scale human trials.'"